A Study Evaluating AB248 Alone or in Combination With Pembrolizumab in Adult Patients With Solid Tumors
Solid Tumor, Non Small Cell Lung Cancer, Melanoma
About this trial
This is an interventional treatment trial for Solid Tumor
Eligibility Criteria
Inclusion Criteria: Age ≥18 years of age at the time consent is signed. Has adequate end organ function per laboratory testing. Pregnancy prevention requirements Has measurable disease per RECIST 1.1 as assessed by the local site Investigator/radiology. Has a performance status of 0 or 1 on Eastern Cooperative Oncology Group scale. Histologic documentation of incurable, locally advanced or metastatic tumor of the type being evaluated in individual cohorts Exclusion Criteria: Has a diagnosis of immunodeficiency. Has a history of a previous, additional malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years. Has known active CNS metastases and/or carcinomatous meningitis. Has an active autoimmune disease Has an active infection requiring systemic therapy. Inability to comply with study and follow-up procedures. Has had a severe hypersensitivity reaction (Grade ≥3) to treatment with pembrolizumab, another monoclonal antibody, or has history of any hypersensitivity to any components of the study treatments or any of their excipients. Has received prior systemic anticancer therapy including investigational agents within 4 weeks (or, if shorter, within 5 half-lives for kinase inhibitors) prior to first dose of study treatment. Has received prior radiotherapy within 2 weeks of start of study treatment or has had a history of radiation pneumonitis. Receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment. Has received previous treatment with another agent targeting the IL-2, IL-7, or IL-15 receptors. Is expected to require any other form of antineoplastic therapy while on study
Sites / Locations
- Investigational Site 002Recruiting
- Investigational Site 009Recruiting
- Invesigational Site 004Recruiting
- Investigational Site 011Recruiting
- Investigational Site 005Recruiting
- Investigational Site 001Recruiting
- Investigational site 012Recruiting
- Investigational Site 008Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
AB248 Monotherapy Dose-Escalation
AB248 + Pembrolizumab Combination Dose-Escalation
AB248 Monotherapy Indication Expansion
AB248 + Pembrolizumab Combination Indication Expansion
AB248 will be administered intravenously as a single agent
AB248 and pembrolizumab will be administered intravenously
AB248 will be administered intravenously as a single agent in disease specific cohorts
AB248 and pembrolizumab will be administered intravenously in disease specific cohorts